KR101160278B1 - Connector for medical liquid-containing packages and medical liquid-containing packages - Google Patents

Connector for medical liquid-containing packages and medical liquid-containing packages Download PDF

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Publication number
KR101160278B1
KR101160278B1 KR1020067007068A KR20067007068A KR101160278B1 KR 101160278 B1 KR101160278 B1 KR 101160278B1 KR 1020067007068 A KR1020067007068 A KR 1020067007068A KR 20067007068 A KR20067007068 A KR 20067007068A KR 101160278 B1 KR101160278 B1 KR 101160278B1
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KR
South Korea
Prior art keywords
connector
self
connection
package
characterized
Prior art date
Application number
KR1020067007068A
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Korean (ko)
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KR20070007248A (en
Inventor
토르스텐 브란덴부르게르
이스마엘 라히미
Original Assignee
프레제니우스 카비 도이치란트 게엠베하
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Family has litigation
Priority to DE10348016A priority Critical patent/DE10348016B4/en
Priority to DE10348016.1 priority
Application filed by 프레제니우스 카비 도이치란트 게엠베하 filed Critical 프레제니우스 카비 도이치란트 게엠베하
Priority to PCT/EP2004/011603 priority patent/WO2005037362A1/en
Publication of KR20070007248A publication Critical patent/KR20070007248A/en
Application granted granted Critical
Publication of KR101160278B1 publication Critical patent/KR101160278B1/en
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=34441987&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=KR101160278(B1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/10Bag-type containers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02Access sites
    • A61M39/04Access sites having pierceable self-sealing members
    • A61M39/045Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20Closure caps or plugs for connectors or open ends of tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/22Valves or arrangement of valves
    • A61M39/26Valves closing automatically on disconnecting the line and opening on reconnection thereof

Abstract

The invention relates to a connection in particular for a package containing an injection or transfusion bag, a medical liquid, comprising a connection 1 provided with an opening 1c in the form of a passage in which the self-sealing membrane 8 is located. The separating portion 17 connected to the connecting portion closes the opening in the form of a passage. On the membrane 8, the connecting element is realized in the form of a connecting portion 13 comprising an inner cone 14 and an outer thread 15, and the membrane 8 is sealed against receiving a syringe cone. The connection of the present invention makes it possible to inject the active substance in the manner of a conventional Luer lock syringe without an injection cannula (needle).

Description

CONNECTOR FOR MEDICAL LIQUID-CONTAINING PACKAGES AND MEDICAL LIQUID-CONTAINING PACKAGES}

The present invention relates to a package containing a medical liquid, in particular a connector for an infusion and transfusion bag, wherein the connection is used to inject the liquid into the bag. Furthermore, the present invention relates to a package containing a medical liquid with an infusion, in particular an infusion bag or transfusion bag.

Infusion bags with infusion and extraction are known from WO 96/23545. The infusion section is used to supply the drug by an infusion syringe with a thin cannula (needle). It comprises a tubular connection closed by a protective cap formed by a break-off. The self-sealing bulkhead is located in the opening region of the connection. The permeable membrane at the junction prevents the partition from contacting the aqueous solution before use of the infusion bag. The extract used for the extraction of the aqueous solution by spikes has a self-sealing partition.

Conventional infusions are characterized in that the self-sealing bulkheads are provided in the opening region of the tubular connection in such a way that the self-sealing bulkheads come into intimate contact with the connection. After separation of the separator, the partition is exposed. This septum is penetrated by an injection needle for injection of the drug. Such injections are also known, for example, from DE 197 28 775 A1 and DE 100 30 474 C1.

Conventional infusions have been used and tested in practice. The drawback however arises from the use of infusion needles for the injection of the active substance. On the one hand, there is a risk that the connection between the injection needle and the septum is loose due to unexpected pulling of the syringe or excessive pressure inside the bag. On the other hand, there is an increased risk of injury to the nursing staff due to the injection needle. The package may also be damaged by the needle if the needle is not handled properly. In addition, the supply of sticky active material becomes difficult due to the narrow cross section of the injection needle. The supply of highly flexible active materials takes a relatively long time for reasons of small cross section.

Conical connections with conical shafts whose cone faces are standardized and conical sleeves are known in the medical art for the connection of medical devices. Non-lockable conical connections with standardized conical faces are called Luer connectors, and lockable conical connections are called Luer lock connectors. Luer locks or luer connectors with conical shafts are called male connectors and connectors with conical sleeves are called female connectors.

DE 196 36 610 A1 describes a filling device for a supply system for the active material, which is connected to the system storage container via a line. The active substance is supplied to the filling device by a conventional syringe without an injection needle. The connection of the syringe to the filling device takes place via the luer lock connector.

A sterile connector for the connection of spikes of a delivery device is disclosed in WO 00/02517, which has a base with recesses in the form of passages closed by separation. The base has a mounting portion for spikes, which mounting portion is essentially cylindrical in shape. The disclosed connector is not intended or suitable for the connection of a luer lock syringe.

US6 186 997 describes an infusion bag with a tube section, which is closed at the end with a slit membrane. The closing cap is screwed with the end of the tube portion.

The problem underlying the present invention is to provide a connector containing a medical liquid, in particular a connector for infusion and transfusion bags, the connector having to be economically produced and able to be operated simply and safely, in particular with viscous activity Allow for a quick supply of the material, the risk of injury of the care staff and package damage should be low.

Another problem of the present invention is to provide a package containing a medical liquid, in particular an infusion bag and a transfusion bag, wherein the package must be able to be operated simply and safely, without risk of injury to the care staff and damage to the package. In particular, the sticky active substance should be able to be injected quickly.

According to the invention, a solution to the abovementioned problems is indicated by the aqueous solution as a feature of claims 1 to 17. Advantageous embodiments of the invention are the main problem of the dependent claims.

The connector according to the invention permits the connection of a conventional syringe to a conical connection, in particular a luer conical connection or a luer lock conical connection, where no injection needle is provided. Since no injection needle with a small cross section is required, larger viscous active materials can also be injected quickly. There is no risk of injury to the care staff or damage to the package. The possibility of screwing the syringe and connector ensures that the connection will not be dropped. The connector has a self-sealing slit membrane located under the upper opening on the connection side. On the self-sealing membrane, the connection of the connection is designed as a connection with an internal cone for the conical axis of the syringe. The self-sealing membrane is slit in a continuous manner to receive the conical axis of the syringe in a sealing manner. After removing the conical shaft, the membrane is closed again, thus preventing liquid from leaking out of the package.

An advantageous embodiment of the invention is provided such that the separator is connected to the connection via an annular rupture zone, so that the separator is securely fixed but nevertheless relatively easy to separate.

In a particularly preferred embodiment, the connection comprises a lower section and an upper section to which the connection is fixed in a snap-in manner. The self-sealing membrane is preferably tightened and fixed between the lower section and the upper section. The assembly is thus simplified. The connection may however also be part.

The self-sealing membrane preferably has a lower annular portion and an upper plate portion. The annular portion of the membrane is preferably tightened between the upper and lower sections of the connection. The membrane is thus more securely fixed. The upper plate portion of the membrane preferably has a trough recess. The trough recess ensures, on the one hand, that the conical shaft of the syringe is guided stably, and on the other hand, that the membrane provides a stable seal after the conical shaft has been pulled out. It was found in the test that the special design of the membrane for immediate resealing was crucial, whereby the sealing of the membrane is still further increased with increasing internal pressure in the package.

The upper plate of the self-sealing membrane preferably follows the central connection and turns into the lower annulus of the membrane. The upper and lower portions of the membrane are elastically connected to one another so that the membrane is deformed in such a way that when the conical shaft of the syringe is inserted, the membrane provides a more stable seal against the connection.

The inner diameter of the annular portion of the self-sealing membrane is preferably smaller than the inner diameter of the recess in the form of a passage of the connection. It has been found that the resealing of the membrane is thus further improved.

The inner cone of the connection part and the self-sealing membrane of the connection are furthermore designed and arranged in such a way that the conical axis of the syringe inserted into the inner cone opens the slit membrane but does not penetrate it.

The connector's detachment is preferably designed with a flat grip to hold it with your thumb and forefinger. The operation is thus simplified.

It is advantageous for the connectors to be injection molded separately, and the connectors can be produced economically in large quantities.

Embodiments of the present invention are described below in more detail with reference to the drawings.

In the drawings,

1 is a side view showing a connector designed as an inlet for a package containing a medical liquid;

FIG. 2 is a cross-sectional view showing a cross section along line A-A of the FIG. 1 connector; FIG.

3 is a plan view of the injection bag with the connector of FIG.

4A is a cross-sectional view showing the connector with the luer syringe separated from the separator.

4B is an enlarged cross-sectional view of detail A of FIG. 4A.

5A is a cross-sectional view of the luer syringe and connector of FIG. 4A while the conical axis of the syringe is inserted into the connector.

FIG. 5B is an enlarged cross-sectional view of detail A of FIG. 5A. FIG.

6A is a cross-sectional view of the luer syringe and connector of FIG. 4A with the conical axis of the syringe inserted into the connector;

FIG. 6B is an enlarged cross-sectional view of detail A of FIG. 6A.

According to the invention the connector is designed as an injection part for injection of the active substance into a package containing a medical liquid, in particular an injection bag or transfusion bag. The connector 20 has a connection 1 with a recess 1c in the form of a passage, the connection 1 comprising a lower section 2 on the package side and an upper section 3 on the connection side in the use position. . The connection part 1 thus has upper and lower openings 1a and 1b. Connector 20 is an injection molded part made of polypropylene.

The lower section 2 of the connection 1 has a lower and upper cylindrical part 4, 5 so that the lower part 4 has a somewhat larger inner diameter than the upper part 5 but is larger than the upper part 5. Have a somewhat smaller outer diameter. The lower part 4 can be pushed into the connecting sleeve of the film bag and welded or glued to the sleeve. However, the lower part 4 can be welded or glued directly into the film bag without the sleeve.

The upper section 3 of the connection 1 is fixed to the lower section 2 in a snap-in manner. For this purpose, the inner wall of the upper section 3 has a circumferential groove 6 in which the circumferential protrusion 7 snaps to the circumferential groove 6 on the outer wall of the upper section 3 when both sections are pressed simultaneously. Equipped.

A self-sealing membrane 8 made of an elastic material called also a partition wall is preferably fitted and fixed between the upper and lower sections 2, 3 with a fine elastic deformation. The membrane 8 has a lower annular part 9 fitted between the upper and lower sections 2, 3 of the connection 1. The lower annular part 9 of the membrane 8 is followed by a central connection 34 which turns into an upper plate part 10 with a trough recess 11.

The connection part 1 has upper and lower shoulders 35 and 36 projecting inwardly. The annular portion 9 lies on the lower shoulder 35 and the plate portion 10 of the membrane 8 lies on the lower shoulder 36. The two parts 9, 10 of the membrane 8 are subjected to compressive stresses in a spring-like manner with respect to the shoulders 35, 36 of the connection 1. The inner diameter of the annular part 9 of the membrane 8 is smaller than the inner diameter of the recess 1c in the form of a passage of the connecting part 1.

The membrane has a continuous slit 12 in the center of the plate portion. Membrane 10 may have only transverse slits or may be cross-shaped or star-shaped slits. The slit 12 actually extends to the entire cross section of the plate portion. The trough recess 11 in the plate 10 may have a curved or straight side.

On the membrane 10, the connection 1 is designed as a connection part 13 with an inner cone 14 and preferably with an external thread 15. The inner cone 14 and the outer thread 15 correspond to the conical axis of the luer lock connector of the conventional syringe so that the conical axis of the luer lock syringe can be inserted in such a way that it seals with the inner cone of the connecting part 13 and It can be screwed on stably in (1). The external thread can also be used without the connection of a luer syringe without a threaded connection.

The connecting portion 13 is connected to the separating portion 17 in the form of a lid via the annular rupture zone 16, and the separating portion closes the upper opening 1a of the connecting portion 13. The separating portion 17 forms an original plug with respect to the connecting portion 1. The separator 17 has a base 18 which is symmetrical to the lower axis of rotation and an upper flat grip 19. The flat grip 19 is provided with a recess 21 formed in the manner of an arrow pointing downwards identifying the connecting part 1 as an injection part. In order to identify the flow direction, the upper section 2 of the connection 1 also has a raised structure 22 formed in the way of an arrow pointing downwards. Arrow 21 is located between the protruding second leg 23 forming a concave grip.

3 shows the injection bag 30 with the injection unit 20. The injection bag 30 includes two film layers 24 welded to the lower and upper edges 25 and the longitudinal edges 26. The connecting sleeve 27 for the infusion 20 and the connecting sleeve 28 for the extraction 29 are welded into the upper edge 25 of the injection bag 30. The tubular connection 1 of the inlet 20 is inserted into the connecting sleeve 27 and welded to the sleeve during sterilization. The tubular connection 1 of the injection part 20 can however be molded in the insert, which is designed in a circular or boat manner and welded between the two film layers.

For the injection of the active substance into the injection solution, the separator 17 of the injection section 20 is twisted or broken so that the self-sealing membrane 8 is exposed and falls or breaks. The conical shaft 31 of the conventional luer lock syringe 32 is inserted into the inner cone 14 of the connecting portion 13, whereby the self-sealing membrane 8 is penetrated. The conical axis of the syringe thereby provides a seal against the inner cone 14 of the connecting portion 13. The screw cap 33 of the syringe 32 is then screwed onto the outer thread 5 of the connecting portion 13, so that the syringe is fixed to the injection portion 20. The active substance can then be injected by the syringe and the syringe is removed again, whereby the membrane tightly closes the injection section.

In addition to the injection section, the injection bag also has an extraction section 29 for drawing out the injection solution, which is welded to the sleeve 28. The extractor, however, is not a subject matter of the invention.

The mode of operation of the self-sealing membrane is described in detail below.

Prior to injection of the conical shaft 31 of the luer syringe 32, the annular and plate portions 9, 10 of the membrane 8 are connected to the shoulders 35, 36 of the connection 1 (FIGS. 4A and 4B). Is placed. When the conical shaft 31 of the syringe 32 is injected, the plate portion 10 of the membrane 8 is deformed and compressed (FIGS. 5A and 5B). The plate portion 10 of the membrane 8 and then the annular portion 9 lose contact with the shoulders 35 and 36 respectively. The plate portion 10 of the membrane is thus compressed against the wall of the connection 1, so that the opening of the connection 1 is stably sealed.

The inner cone 14 of the connecting portion 13 and the self-sealing membrane 8 of the connecting portion 1 have a conical shaft 31 of the syringe 32 inserted into the inner cone which opens the slit membrane 8 but not It is designed and arranged not to penetrate (FIGS. 6A and 6B).

The membrane 8 is keyed with the lower section 2 of the connecting part 1 so that the gaped membrane 8 is stably fixed. For this purpose, the membrane 8 has an outer groove 37 on its lower face, and the outer protrusion 38 engages the upper face of the lower section 2 of the connection 1 with the outer groove 37. .

The connection part for the package containing the medical liquid and the package containing the medical liquid using the present invention can be widely used in the medical field due to its stability, convenience and economy, as well as a laboratory requiring high stability. Or the like.

Claims (19)

  1. Connectors for packages containing medical liquids,
    A connection 1 having a channel-shaped recess 1c, in which the self-sealing membrane 8 is located, the recess having a package side lower opening and a connection side upper opening 1b, 1a. Connection part 1,
    In the connector for a package containing a medical liquid, the channel-shaped recess (1c) is closed and has a separating portion (17) connected to the connecting portion (1) above the connecting side opening portion (1a).
    The connection 1 comprises a connecting portion 13 having an inner cone 14 extending above the self-sealing membrane 8, so that the self-sealing membrane 8 receives the conical shaft of the syringe in a sealing manner. A connector for a package containing a medical liquid, characterized in that it becomes a slit.
  2. 2. A package containing a medical liquid as claimed in claim 1, characterized in that the connection part of the connection part (1) is designed as a female luer connector (13) with an inner cone (14). Connector for
  3. 3. A medical liquid containing liquid as claimed in claim 2, characterized in that the female luer connector (13) of the connection part (1) is designed as a female luer connector with an inner cone (14) and an outer thread (15). Connector for the package.
  4. 4. A package containing a medical liquid according to any one of claims 1 to 3, characterized in that the separation part (17) is connected to the connection part (1) via an annular rupture zone (16). Connector for
  5. 4. The connection according to claim 1, wherein the connection part 1 comprises a lower section 2 and an upper section 3, the sections being fixed in a snap-in manner. A connector for a package containing a medical liquid, characterized in that.
  6. 6. Connector according to claim 5, characterized in that the self-sealing membrane (8) is sandwiched and fixed between the lower and upper sections (2, 3).
  7. The self-sealing membrane (8) according to any one of the preceding claims, wherein the self-sealing membrane (8) comprises an upper annular portion (10) with a lower annular portion (9) and a mold-shaped recess (11). A connector for a package containing a medical liquid, characterized in that it is provided.
  8. 8. Package according to claim 7, characterized in that the upper plate portion (10) is followed by a central mediating portion (34) which turns into a lower annulus (9) of the self-sealing membrane (8). Connector for
  9. 8. A medical liquid containing a medical liquid as claimed in claim 7, characterized in that the annular part (9) of the self-sealing membrane (8) is sandwiched between the lower and upper sections (2, 3) of the connection part (1). Connector for the package.
  10. Package according to claim 7, characterized in that the connection part (1) has an inwardly projecting shoulder (35) on which the annular part (9) of the self-sealing membrane (8) lies. Connector for
  11. 8. A package containing medical liquid according to claim 7, characterized in that the connection (1) has an inwardly projecting shoulder (36) on which the plate (10) of the self-sealing membrane (8) is placed. Connector for
  12. 12. The medical liquid according to claim 11, characterized in that the plate-shaped portion 10 of the self-sealing membrane 8 is subjected to compressive stress in a spring-like manner against the inwardly protruding shoulder 36. Connector for containing packages.
  13. 8. A package according to claim 7, characterized in that the annular part (9) of the self-sealing membrane (8) is keyedly connected to the lower section (2) of the connection part. Connector.
  14. 8. The inner diameter of the annular part 9 of the self-sealing membrane 8 is characterized in that it is smaller than the inner diameter of the recess 1c in the form of a channel of the connecting part 1. Connector for packages containing medical liquids.
  15. 4. The syringe according to claim 1, wherein the inner cone 14 of the connecting part 13 and the self-sealing membrane 8 of the connecting part 1 are inserted into the inner cone 14. And a conical shaft of which is designed and positioned in such a way that it opens the slit membrane but does not penetrate it.
  16. 4. Connector according to one of the preceding claims, characterized in that the separating part (17) is designed with a flat grip.
  17. A package for medical liquids, comprising a connector (20) according to any one of the preceding claims.
  18. 4. The method according to any one of claims 1 to 3,
    The package is a connector for a package containing a medical liquid, infusion bag or transfusion bag.
  19. 18. The method of claim 17,
    Wherein said package is an infusion bag or transfusion bag.
KR1020067007068A 2003-10-15 2004-10-15 Connector for medical liquid-containing packages and medical liquid-containing packages KR101160278B1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
DE10348016A DE10348016B4 (en) 2003-10-15 2003-10-15 Connector for medical fluid containing packaging and packaging for medical fluids
DE10348016.1 2003-10-15
PCT/EP2004/011603 WO2005037362A1 (en) 2003-10-15 2004-10-15 Connector for medical liquid-containing packages and medical liquid-containing packages

Publications (2)

Publication Number Publication Date
KR20070007248A KR20070007248A (en) 2007-01-15
KR101160278B1 true KR101160278B1 (en) 2012-06-28

Family

ID=34441987

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020067007068A KR101160278B1 (en) 2003-10-15 2004-10-15 Connector for medical liquid-containing packages and medical liquid-containing packages

Country Status (18)

Country Link
US (1) US7857802B2 (en)
EP (2) EP1673135B1 (en)
JP (1) JP4684233B2 (en)
KR (1) KR101160278B1 (en)
CN (1) CN100577234C (en)
BR (1) BRPI0415438B1 (en)
CA (1) CA2542408C (en)
DE (1) DE10348016B4 (en)
DK (1) DK1673135T3 (en)
ES (1) ES2405262T3 (en)
HK (1) HK1089080A1 (en)
MX (1) MXPA06004241A (en)
NO (1) NO339635B1 (en)
PL (1) PL1673135T3 (en)
PT (1) PT1673135E (en)
SI (1) SI1673135T1 (en)
WO (1) WO2005037362A1 (en)
ZA (1) ZA200602538B (en)

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JP2007508081A (en) 2007-04-05

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